PolyMedix has initiated dosing and commenced a second clinical trial, a phase 1B pilot proof of concept study, in the US with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the FDA.
PMX-60056 represents a new class of drug, (heptagonist) and is believed to be the only reversing agent for heparin and the Low Molecular Weight Heparins (LMWH) in clinical development.
The company said that the second clinical trial is being conducted in healthy volunteers, and will involve first administering heparin to healthy subjects, and then afterwards administering a single dose of PMX-60056.
The study is intended to assess the safety of using PMX-60056 in heparinized subjects, and will also measure the ability of PMX-60056 to neutralize heparin and normalize blood clotting time. The study utilises a crossover double-blind design, and is planned to be conducted in a total of six subjects. Results are expected by the end of 2009.
Following the clinical trial, significant additional clinical studies and regulatory submissions will be required to obtain regulatory approval from the FDA and other regulatory bodies before PMX-60056 could be commercially sold.
PMX-60056 was designed to bind to the pentasaccharide region found on heparin and LMWH. In previous studies conducted by PolyMedix and other groups, PMX-60056 has been demonstrated to reverse the action of heparin in isolated human plasma, isolated human whole blood, and in animal studies in rats and dogs.